Our client asked:

How should we organise our Regulatory Affairs function to be more proactive and strategically minded, whilst continuing to fulfil the essential tactical requirements of its remit?

The goal was to build an agile team fully aligned with other teams across the business and competent in compliance, horizon scanning, strategy, and external advocacy.

The project story:

• Our brief comprised three elements
• Develop a future vision for the regulatory function (and build alignment across the organisation).
• Identify gaps to be filled / opportunities to be unlocked to realise the vision: looking at structure, staffing/resources/technology, skills/competencies, systems/practices, and culture/expectations.
• Develop recommendations for changes to be made with a roadmap/milestones to guide the transformation.
• We interviewed senior commercial stakeholders from across the business (in US, EMEA, LatAm and Asia Pac) to understand their view on the gaps, challenges and unmet needs relating to regulatory affairs, their views on the competences/resources required to address these, and potential trade-offs which would need to be considered within their lean culture.
• We summarised findings from these discussions in a series of workshops with the client’s key stakeholders and developed a set of recommendations which included a new organisational structure, the adoption of tools and systems across regions, and the sharing of best practice between internal teams.

Results: deliverables and outcomes

We outlined the regulatory team's current capabilities and set out the new vision, including the key changes proposed (with rationale) and an 18-month implementation roadmap. The recommendations were implemented (with minor revisions), and Sagentia Innovation continued to provide support and advice to the client over subsequent months.

Expertise and domain knowledge:

• Consumer
• FMCG
• Food and beverage
• Regulatory affairs
• Horizon scanning
• Strategic roadmaps
• Research
• Workshops
• Team development